COVID pills

The U.S. Food and Drug Administration issued an emergency use authorization (EUA) for two oral pills Pfizer’s Paxlovid and Merck’s Molnupiravir. These pills have been authorized for the treatment of mild-to-moderate coronavirus disease (COVID-19) in adults with positive results of direct SARS-CoV-2 testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death.

Both pills should be started as soon as possible after diagnosis of COVID-19 and within five days of symptom onset.

None of these pills are a substitution for vaccination

Patients will need a positive COVID-19 test to get a prescription.

These pills have NOT been authorized for pre or post-exposure prevention of COVID-19 or for initiation of treatment in those requiring hospitalization due to severe or critical COVID-19.

Here is some information about the two pills.

A) Paxlovid – preferred due to better efficacy, 88% reduction in COVID related hospitalizations compared with placebo

1. Paxlovid is administered as three tablets taken together orally twice daily for five days, for a total of 30 tablets.

2. Paxlovid is not authorized for use for longer than five consecutive days.

3. Paxlovid is authorized for Covid patients age 12 and over

4. Paxlovid is not recommended in patients with severe kidney or severe liver impairment

5. Paxlovid consists of nirmatrelvir, which inhibits a SARS-CoV-2 protein to stop the virus from replicating, and ritonavir, which slows down nirmatrelvir’s breakdown to help it remain in the body for a longer period at higher concentrations

6. Possible side effects of Paxlovid include impaired sense of taste, diarrhea, high blood pressure and muscle aches. 

 

B) Molnupiravir – authorized for treatment in cases where alternative COVID-19 treatment options authorized by the FDA are not accessible or clinically appropriate, 30% reduction in COVID related hospitalizations compared with placebo

1. Molnupiravir is administered as four 200 milligram capsules taken orally every 12 hours for 5 days, for a total of 40 capsules.

2. Molnupiravir is not authorized for use in patients younger than 18 years of age because it may affect bone and cartilage growth

3. Molnupiravir is not authorized to be used for longer than 5 consecutive days

4. Molnupiravir is not recommended for use during pregnancy. Females of childbearing potential are advised to use a reliable method of birth control correctly and consistently during treatment with molnupiravir and for four days after the final dose. Males of reproductive potential who are sexually active with females of childbearing potential are advised to use a reliable method of birth control correctly and consistently during treatment with molnupiravir and for at least three months after the final dose. 

5.Molnupiravir is a medication that works by introducing errors into the SARS-CoV-2 virus’ genetic code, which prevents the virus from further replicating

6.Possible side effects observed in the trial included diarrhea, nausea and dizziness.

Both pills are expected to be available by early next week. The federal government will allocate the antiviral pills to states, which can then distribute them to local health departments and pharmacies, as was done with Covid vaccines. The government will also distribute the pills directly to community health centers.

 

Sources- https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-additional-oral-antiviral-treatment-covid-19-certain

https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-first-oral-antiviral-treatment-covid-19

https://www.nytimes.com/2021/12/22/health/pfizer-covid-pill-fda-paxlovid.html

 

Author
Ritu Aggarwal

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